White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA

NCT04519879 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 19296NCI-2019-05587P30CA033572
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 7

Brief Summary

This phase II trial studies how well white button mushroom supplement works in reducing prostate-specific antigen (PSA) levels in patients with prostate cancer that has come back (recurrent) or has favorable risk and has not undergone any therapy (therapy naive). PSA is a blood marker of prostate growth. White button mushroom supplement may affect PSA level, various parameters of immune system and levels of hormones that may have a role in prostate cancer growth.

Conditions

Prostate Adenocarcinoma; PSA Failure; PSA Progression; Recurrent Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)

  For continuous variables, descriptive statistics (number \[n\], mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.

  At 12 weeks

• Relative change in PSA (Cohort 2)

  The relative difference in PSA will be measured as log (48 week PSA/baseline PSA). Undetectable PSA at 48 weeks will be coded as the low end of the lab measurement range for PSA. This measure of relative difference will be compared between the white button supplement (WBM) + active surveillance and active surveillance only patients. For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.

  Baseline up to 48 weeks

Secondary Outcomes (5)

• Incidence of adverse events

  Up to 48 weeks

• Proportion of patients with PSA response (Cohort 1)

  Up to 48 weeks

• Time to PSA progression (Cohort 1)

  Time from randomization to PSA progression, assessed up to 48 weeks

• Time to initiation of additional therapy (Cohort 2)

  Baseline up to 48 weeks

• Time to progression (Cohort 2)

  From randomization to progression, assessed up to 48 weeks

Other Outcomes (3)

• Change in temporal levels of circulating myeloid-derived suppressor cells (MDSCs)

  Baseline to 48 weeks

• Change in temporal levels of pro-/anti-inflammatory mediators

  Baseline up to 48 weeks

• Sexual function

  Up to 48 weeks

Study Arms (4)

Arm IA (white mushroom extract)

EXPERIMENTAL

Patients receive white button mushroom extract PO BID on day 1. Treatment repeats every 4 weeks for cycles 1-3 then every 12 weeks for cycles 4-6 (36 weeks) in the absence of disease progression or unacceptable toxicity.

Other: Questionnaire Administration; Drug: White Button Mushroom Extract

Arm IB (clinical observation)

ACTIVE COMPARATOR

Patients undergo clinical observation for 12 weeks. If PSA continues to increase, patients have the option to receive the white button mushroom extract as in arm IA.

Other: Clinical Observation; Other: Questionnaire Administration

Arm IIA (white mushroom extract)

EXPERIMENTAL

Patients receive white mushroom extract PO BID on day 1. Treatment repeats every 12 weeks for 4 cycles (48 weeks) in the absence of disease progression or unacceptable toxicity.

Other: Questionnaire Administration; Drug: White Button Mushroom Extract

Arm IIB (active surveillance)

ACTIVE COMPARATOR

Patients undergo active surveillance for 48 weeks.

Other: Patient Observation; Other: Questionnaire Administration

Interventions

Clinical Observation OTHER

Undergo clinical observation

Also known as: observation

Arm IB (clinical observation)

Patient Observation OTHER

Undergo active surveillance

Also known as: Active Surveillance, deferred therapy, expectant management, observation, Watchful Waiting

Arm IIB (active surveillance)

Questionnaire Administration OTHER

Ancillary studies

Arm IA (white mushroom extract); Arm IB (clinical observation); Arm IIA (white mushroom extract); Arm IIB (active surveillance)

White Button Mushroom Extract DRUG

Given PO

Also known as: WBM Extract

Arm IA (white mushroom extract); Arm IIA (white mushroom extract)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• For therapy naive favorable risk prostate cancer (cohort 2 only): agreement to undergo baseline and 48 week prostate biopsy
• Willing to forego non-study supplements containing mushroom for the duration of the study
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Histologically or cytologically confirmed history of adenocarcinoma of the prostate
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: PSA failure defined as:
• PSA of \>= 0.2 ng/mL that has increased above nadir following prostatectomy, OR
• PSA increase of 2.0 ng/mL above post-therapy nadir if other primary local therapy was used instead of prostatectomy
• NOTE: PSA value must be increasing based on 2 consecutive measurements taken at least 2 weeks apart
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Testosterone levels \> 50 ng/dL
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Received any number of primary local therapies, defined as:
• Radical prostatectomy
• External beam radiation therapy
• Radioactive seed implantation
• Cryotherapy

You may not qualify if:

• Other concomitant investigational anti-cancer therapy/ vaccines/biologics, corticosteroids with \> 10 mg of prednisone equivalent dose
• Therapy with mushroom supplements within last 3 months of randomization
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant androgen derivation therapy lasting \> 24 months or within 6 months prior to day 1 of protocol therapy
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant chemotherapy within 6 months prior to day 1 of protocol therapy
• BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Prior therapy for recurrent prostate cancer (unless given as a component of attempted curative salvage treatment including salvage radiation therapy, and completed \> 6 months before day 1 of protocol therapy):
• Chemotherapy
• Androgen deprivation therapy
• Immunotherapy
• Targeted therapy
• Known history of allergic reaction to mushrooms
• Clinically significant uncontrolled illness
• Active infection requiring treatment
• Uncontrolled congestive heart failure, cardiac arrhythmia
• History of other primary non-skin malignancy within previous 2 years unless treated with curative intent and in remission
• Any other condition that would, in the Investigator?s judgment, contraindicate the patient?s participation in the clinical study due to safety concerns with clinical study procedures

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Glendora

Glendora, California, 91741, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

City of Hope Rancho Cucamonga

Rancho Cucamonga, California, 91730, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

City of Hope West Covina

West Covina, California, 91790, United States

Location

Related Publications (1)

• Wang X, Ma S, Twardowski P, Lau C, Chan YS, Wong K, Xiao S, Wang J, Wu X, Frankel P, Wilson TG, Synold TW, Presant C, Dorff T, Yu J, Sadava D, Chen S. Reduction of myeloid-derived suppressor cells in prostate cancer murine models and patients following white button mushroom treatment. Clin Transl Med. 2024 Oct;14(10):e70048. doi: 10.1002/ctm2.70048.

  PMID: 39390760 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting; Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Study Officials

• Clayton S Lau

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: August 20, 2020
• Study Start: May 10, 2021
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (7)